Executive Summary:
The Central Drugs Standard Control Organisation (CDSCO) announces that the National Institute of Biologicals (NIB) is now fully equipped for Quality Control Testing and Lot release of Viral Load Monitoring Quantitative kits for HIV, HCV, and HBV. State Drugs Controllers and Zonal/Sub-Zonal/Port Offices of CDSCO are requested to refer these kits to NIB for test evaluation along with the relevant licenses. NIB has been notified as a Central Medical Device Testing Laboratory (CMDTL) for HIV, HCV, and HBsAg diagnostics.
Key Points / Main Content:
* **NIB Accreditation and Capabilities:**
* NIB is a notified CMDTL for HIV, HCV, and HBsAg diagnostics.
* NIB is NABL accredited (ISO/IEC 17025:2005) for HIV, HCV, HBV, and Syphilis serology.
* NIB has standardized and validated Quality Control testing for Viral Load Monitoring (Quantitative) kits for HIV, HCV, and HBV.
* **Quality Control Testing:**
* Viral load monitoring kits for HIV, HCV, and HBV may be referred to NIB for test evaluation.
* A copy of the Import/Manufacturing license must accompany the kits.
* The sample size required for test evaluation is 48 tests plus kit-specific controls and calibrators.
Impact Analysis:
State Drugs Controllers and Zonal/Sub-Zonal/Port Offices of CDSCO
* *Impact:* Responsible for directing viral load monitoring kits for HIV, HCV, and HBV to NIB for quality control testing.
* *Action Required:* Refer viral load monitoring kits to NIB for test evaluation, accompanied by the Import/Manufacturing license, and ensure the sample size meets requirements.
Manufacturers/Importers of Viral Load Monitoring Kits:
* *Impact:* Required to submit their kits to NIB for quality control testing before lot release.
* *Action Required:* Submit viral load monitoring kits to NIB with a copy of their Import/Manufacturing license, ensuring a sample size of 48 tests plus kit-specific controls and calibrators is provided.
Key Entities Referenced
Central Drugs Standard Control Organisation: Regulatory body in India responsible for drug regulation.
Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare, Government of India.
Ministry of Health Family Welfare: Government ministry responsible for health policy in India.
National Institute of Biological, Noida, Uttar Pradesh: An autonomous institution under the Ministry of Health & Family Welfare, Government of India, involved in quality control testing.
HIV: Human Immunodeficiency Virus, a retrovirus that causes AIDS.
HCV: Hepatitis C Virus, a virus that causes Hepatitis C.
HBV: Hepatitis B Virus, a virus that causes Hepatitis B.
ISOIEC 17025:2005: International standard for testing and calibration laboratories.
Central Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Diagnostic Division)
FDA Bhawan, Kotla Road, New Delhi-110002
F. No. IVD/Misc/115/DCGI/18 Dated: 9 A
JUL 2018
J;
All State Drugs Controller
All Zonal/ Sub Zonal/ Port Offices of CDSCO
Subject:- Quality Control testing of Viral load Monitoring kits for HIV, HCV &
HBV - Reg.
Sir,
This is to inform you that Disease specific In-Vitro Diagnostic laboratory of
NIB is engaged in doing quality testing of serological as well as molecular diagnostic
kits (Qualitative) of HIV, HCV & HBV. The Institute has been notified as Central
Medical Device Testing Laboratory (CMDTL) by Government of India vide Gazette
no. S.0.2237 (E) dated 1* June 2018 for diagnostics for HIV, HCV & HBsAg.
Laboratory has a Quality Management System in place and is NABL accredited in
accordance with the standard ISO/IEC 17025:2005 for HIV, HCV, HBV and Syphilis
serology. The laboratory is regularly participating in PT/EQAS for serology organized
by NRL, Australia since 2009 and has been scoring successfully 100% results in
every quarter of every year.
Further, the Institute has standardized and validated the Quality Control
testing of Viral Load Monitoring (Quantitative) for kit for HIV, HCV & HBV. The
Institute is now fully equipped to do Quality Control Testing and Lot release of these
kits. Therefore it is requested that viral load monitoring (Quantitative) kits for HIV,
HCV & HBV may be referred to NIB for Test/ evaluation purpose along with copy of
Import/ Manufacturing licence. The sample size required for test/evaluation purpose
is 48 tests plus kit specific control and calibrator.
This is for your information and necessary action
Yours faithfully,
xh
(Dr. S ESwara Reddy)
Drugs Controller General (1)
Enclosure :- Copy of NIB letter no.1/Dir.off/2018/NIB, dated 28/06/2018
Copy to;
4. The Director, National Institute of Biological, A-32, Sector-62 (Industrial Area),
Noida.
2. CDSCO website.A A-32, Sector - 62 (institutional Area)
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Dated ; 28.06.2018
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To,
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Directorate General Health Services,
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specific control and calibrator.
Your early action in this regard will be highly appreciated.
Yours sincerely
(Dr. Surinder Singh)
Director